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510(k) Data Aggregation

    K Number
    K250727
    Device Name
    AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
    Manufacturer
    Hangzhou Alltest Biotech Co.,Ltd
    Date Cleared
    2025-04-04

    (24 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    NFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |-------------------|---------------| | Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Benzodiazepine (BZO) | 300 ng/mL | | Cocaine (COC) | 150 ng/mL or 300 ng/mL | | Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 ng/mL or 2000 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | | Fentanyl(FYL) | 1 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Tramadol (TRA) | 100 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | 6-monoacetylmorphine (6-MAM) | 10 ng/mL | AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |-------------------|------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 or 1000 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Benzodiazepine (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 or 300 | | Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 | | Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 | | Morphine (MOP/OPI) | Morphine | 300 or 2000 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 | | Fentanyl (FYL) | Fentanyl | 1 | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | | Tramadol (TRA) | Tramadol | 100 | | Propoxyphene (PPX) | Propoxyphene | 300 | | 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 | AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format.
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    K Number
    K244043
    Device Name
    AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
    Manufacturer
    Hangzhou Alltest Biotech Co.,Ltd
    Date Cleared
    2025-02-27

    (59 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGI, NGL, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    NFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |---------------------------------------------------------------------------------------------|-------------------| | Amphetamine (AMP) | 500 or 1000 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Benzodiazepines (BZO) | 300 ng/mL | | Cocaine (COC) | 150 or 300 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 or 1000 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 or 2000 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | | Tramadol (TRA) | 100 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Fentanyl(FYL) | 1 ng/mL | | 6-monoacetylmorphine (6-MAM) | 10 ng/mL | | AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination | | est Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |--------------------------------------------------------------|-------------------------------------------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 or 1000 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Benzodiazepines (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 or 300 | | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine | 300 | | Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 | | Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 | | Morphine (MOP/OPI) | Morphine | 300 or 2000 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 1-nor-Δ9-THC-9 COOH | 50 | | Tramadol (TRA) | Tramadol | 100 | | Propoxyphene (PPX) | Propoxyphene | 300 | | Fentanyl(FYL) | Fentanyl | 1 | | 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 | AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K243996
    Device Name
    AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
    Manufacturer
    Assure Tech LLC
    Date Cleared
    2025-02-07

    (43 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    NFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AssureTech Panel Dip Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only. The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only. The AssureTech Multi-drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test panel can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
    The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP. Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
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    K Number
    K242498
    Device Name
    Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC
    Manufacturer
    Aicheck Biotech, Inc.
    Date Cleared
    2024-10-01

    (40 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    NFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pocguide Multi-Drug Test Panel OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug ( Identifier) | Cut-off level | |----------------------------------------------------------|-------------------------| | Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Benzoylecognine (COC) | 300 ng/mL or 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (OPI2000/MOP300) | 2000 ng/mL or 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | The single or multi-test panels can consist of up to the above listed analytes in any combination. The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. For over-the-counter use. For in vitro diagnostic use only
    Device Description
    Pocguide™ Multi-Drug Test Panel and Pocguide™ Multi-Drug Test Panel OTC are immunochromatographic assays that use a lateral flow system for the qualitative detection of single drugs in human urine at or above the cut-off levels as indicated. The products are single use in vitro diagnostic devices. This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K242540
    Device Name
    AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel
    Manufacturer
    Hangzhou Alltest Biotech Co.,Ltd
    Date Cleared
    2024-09-27

    (32 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    NFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AllTest Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off leve | |--------------------------------------------------------------|--------------| | Amphetamine (AMP) | 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 150 ng/mL | | Methamphetamine (MET) | 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | | Fentanyl(FYL) | 1 ng/mL | AllTest Multi-Drug Urine Test Panel can be a single drug test panel or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |---------------------|---------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Oxazepam (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 | | Methamphetamine (MET) | d-Methamphetamine | 500 | | Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 | | Morphine (MOP/OPI) | Morphine | 300 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 | | Fentanyl(FYL) | Fentanyl | 1 | AllTest Multi-Drug Rapid Urine Test Panel can be a single drug test panel or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinquish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    AllTest Multi-Drug Urine Test Panel and AllTest Multi-Drug Rapid Urine Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a panel format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K242077
    Device Name
    PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
    Manufacturer
    Aicheck Biotech, Inc.
    Date Cleared
    2024-08-14

    (29 days)

    Product Code
    NFT
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    NFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PocguideTM Multi-Drug Test Cup OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: Drug (Identifier) Amphetamine (AMP) Buprenorphine (BUP) Secobarbital (BAR) Oxazepam (BZO) Benzoylecgonine (COC) 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) Methamphetamine (MET) Methylenedioxymethamphetamine (MDMA) Morphine (OPI2000/MOP300) Methadone (MTD) Oxycodone (OXY) Phencyclidine (PCP) Nortriptyline (TCA) Marijuana (THC) Cut-off level 1000 ng/mL or 500 ng/mL 10 ng/mL 300 ng/mL 300 ng/mL 300 ng/mL or 150 ng/mL 300 ng/mL 1000 ng/mL or 500 ng/mL 500 ng/mL 2000 ng/mL or 300 ng/mL 300 ng/mL 100 ng/mL 25 ng/mL 1000 ng/mL 50 ng/mL The single or multi-test cups can consist of up to the above listed analytes in any combination. For over-the-counter use. The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. PocguideTM Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------------| | Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Benzoylecgonine (COC) | 300 ng/mL or 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (OPI2000/MOP300) | 2000 ng/mL or 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | The single or multi-test cups can consist of up to the above listed analytes in any combination. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
    Device Description
    Pocguide™ Multi-Drug Test Cup OTC and Pocguide™ Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
    Ask a Question
    K Number
    K241428
    Device Name
    AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
    Manufacturer
    Hangzhou Alltest Biotech Co.,Ltd
    Date Cleared
    2024-06-17

    (28 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    NFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |--------------------------------------|---------------| | Amphetamine (AMP) | 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 150 ng/mL | | Methamphetamine (MET) | 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | | Fentanyl(FYL) | 1 ng/mL | AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |--------------------------------------|-----------------------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Oxazepam (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 | | Methamphetamine (MET) | d-Methamphetamine | 500 | | Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 | | Morphine (MOP/OPI) | Morphine | 300 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 | | Fentanyl(FYL) | Fentanyl | 1 | AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K233062
    Device Name
    BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
    Manufacturer
    VivaChek Biotech (Hangzhou) Co., Ltd
    Date Cleared
    2023-11-02

    (37 days)

    Product Code
    NFT, LCM, NFV, NFW, NFY, NGG, NGL, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    NFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioSieve™ Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------------| | Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 300 ng/mL or 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | BioSieve™ Multi-Drug Urine Test Panel offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. BioSieve™ Multi-Drug Urine Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1.5-dimenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: | Drug | Calibrator | Cut-off (ng/mL) | |--------------------------------------------------------------|-------------------------------------------------------|-----------------| | Amphetamine (AMP) | D-Amphetamine | 1,000 or 500 | | Barbiturates (BAR) | Secobarbital | 300 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Oxazepam (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 300 or 150 | | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine | 300 | | Ecstasy (MDMA) | D,L- Methylenedioxy-methamphetamine | 500 | | Methamphetamine (MET) | D-Methamphetamine | 1,000 or 500 | | Morphine (MOP/OPI) | Morphine | 2,000 or 300 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Propoxyphene (PPX) | Propoxyphene | 300 | | Nortriptyline (TCA) | Nortriptyline | 1,000 | | Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 | BioSieve™ Multi-Drug Urine Test Panel Rx offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    The BioSieve™ Multi-Drug Urine Test Panel and BioSieve™ Multi-Drug Urine Test Panel Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test BioSieve™ Panel and two desiccants, and a package insert. The BioSieve™ Multi-Drug Urine Test Panel is intended for over-the-counter use and the BioSieve™ Multi-Drug Urine Test Panel Rx is intended for prescription use.
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    K Number
    K222667
    Device Name
    Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
    Manufacturer
    Vivachek Biotech (Hangzhou) Co., Ltd
    Date Cleared
    2022-11-10

    (65 days)

    Product Code
    NFT, LCM, NFV, NFW, NFY, NGG, NGL, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    NFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wisdiag Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------------| | Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 300 ng/mL or 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Marijuana (THC) | 50 ng/mL | Wisdiag Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may vield positive results for the prescription drugs Buprenorphine. Oxazepam, Secobarbital. Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. Wisdiag Multi-Drug Urine Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------------| | Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 300 ng/mL or 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Cannabinoids (THC) | 50 ng/mL | Wisdiag Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may vield positive results for the prescription drugs Buprenorphine. Oxazepam, Secobarbital. Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are rapid, singleuse in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Wisdiag Cup and two desiccants, and a package insert. The Wisdiag Multi-Drug Urine Test Cup is intended for over-the-counter use and the Wisdiag Multi-Drug Urine Test Cup Rx is intended for prescription use.
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    K Number
    K221871
    Device Name
    Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
    Manufacturer
    Healstone Biotech Inc
    Date Cleared
    2022-08-30

    (63 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Product Code :

    NFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Healstone Accurate ™ Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication. This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (CCMS) is the preferred method confirmation test. For in vitro diagnostic use only. The Healstone Accurate ™ Drug of Abuse Urine Test Cup Rx is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication. This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. It is intended for prescription use. For in vitro diagnostic use only.
    Device Description
    The Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse Urine Test Cup Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Accurate™ Cup and two desiccants, and a package insert. The Healstone Accurate™ Drug of Abuse Urine Test Cup is intended for over-the-counter use and the Healstone Accurate™ Drug of Abuse Urine Test Cup Rx is intended for prescription use.
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